Comparison of three bacterial detection methods under routine conditions.
BACKGROUND AND OBJECTIVES: Since 2004, bacterial screening of platelets has been required in the USA and is also done on a voluntary basis in many European countries. The German Red Cross blood donor services conducted a prospective multicentre study in order to investigate the prevalence of bacterially contaminated pool platelet concentrates and apheresis platelet concentrates. This substudy compares three different bacterial detection systems. STUDY DESIGN AND METHODS: Platelet concentrates were tested in parallel with BacT/ALERT, Scansystem and Pall eBDS (n = 6307) in pool platelets. Apheresis platelets were tested in parallel with BacT/ALERT and Pall eBDS (n = 4730). All initially positive results were evaluated by a standardized procedure including evaluation by a microbiology reference laboratory. RESULTS: One in 6307 pool platelets were confirmed positive by BacT/ALERT, whereas Pall eBDS and Scansystem failed to detect these samples. Only three samples were initially reactive with Pall eBDS without proof of any bacteria strains. The rate of false-positive results was substantially higher for BacT/ALERT (0.25%, 28 in 11,037 tested samples) than for eBDS (0.03%, 3 in 11 037 tested samples) or Scansystem (0.0%, 0 in 6307 tested samples). Three of 4730 apheresis platelets were confirmed positive by BacT/ALERT. These were negative with Pall eBDS. CONCLUSION: Sensitivity was best for BacT/ALERT, whereas specificity was enhanced for Pall eBDS and Scansystem. Scansystem required specially trained staff, whereas BacT/ALERT and Pall eBDS were easy, quick, user-friendly and objective methods.